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510(k) Data Aggregation
(261 days)
EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
This instrument has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, display monitor, EndoTherapy accessories such as an aspiration biopsy needle. This instrument is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound guided needle aspiration within the airways, tracheobronchial tree, and esophagus.
The BF-UC190F has been designed to be used with the video system center, light source, documentation equipment, display monitor, and Endo Therapy accessories such as an aspiration biopsy needle. The BF-UC190F is intended for endoscopic real-time ultrasound imaging for performing endoscopic ultrasound guided needle aspiration within the airways, tracheobronchial tree, and esophagus. The BF-UC190F is a flexible video endoscope and a modification of the XBF-UC180F-DT8 which was previously cleared under K070983. The BF-UC190F consists of three parts: the control section, the insertion section, and the connector section.
The Olympus BF-UC190F Endoscopic Ultrasound Bronchofibervideoscope underwent several performance tests to demonstrate its substantial equivalence to the predicate device, the XBF-UC180F-DT8 (BF-UC180F), and confirm its safety and effectiveness.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria alongside performance data in a direct comparative format for each test. Instead, it states that various tests were conducted and the device conforms to or complies with relevant standards and guidance documents, implying that meeting these standards served as the acceptance criteria.
| Acceptance Criteria (Implied from Compliance Statements) | Reported Device Performance (Summary) |
|---|---|
| Ultrasound Output Display: Conformance to IEC 60601-2-37 Edition 2.0 2007 and FDA Guidance Document, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." | Output Display for BF-UC190F conducted and conforms to the specified IEC standard and FDA guidance. |
| Reprocessing Validation Testing: Conformance to Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling." | Reprocessing instruction and method validation testing conducted, and documentation provided as recommended by the guidance. |
| Biocompatibility Testing: Conformance to FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." | Biocompatibility testing conducted in accordance with the specified FDA guidance and ISO standard. |
| Software Verification and Validation Testing: Conformance to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." | Software verification and validation testing conducted, and documentation provided as recommended by the FDA guidance. |
| Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with ANSI/AAMI ES60601-1:2005/A2:2012/(R)2012, IEC 60601-2-18:2009 (for safety), and IEC 60601-1-2:2007 (for EMC). | Electrical safety and EMC testing conducted; the system complies with the specified ANSI/AAMI and IEC standards. |
| Performance Testing - Bench (Thermal Safety, Mechanical Durability): Meets design specifications and requirements, including process verification, design verification, and design validation. | Thermal safety and mechanical durability bench tests conducted and performed as intended, meeting design specifications. |
| Risk Analysis: Conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007 and human factors validation in accordance with FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices." | Risk analysis conducted, design verification tests and acceptance criteria identified and performed based on this assessment. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the test sets (e.g., number of units tested for thermal safety or mechanical durability, number of biological samples for biocompatibility). It generally states that "testing were conducted."
Data provenance is not explicitly mentioned in terms of "country of origin of the data" or "retrospective or prospective." All tests appear to be prospective bench tests performed by the manufacturer to validate the device's design and compliance with regulatory standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The testing described (e.g., electrical safety, EMC, biocompatibility, mechanical durability) are typically engineering and laboratory-based tests that do not involve "experts to establish ground truth" in the clinical sense (like radiologists marking images). Instead, the "ground truth" for these tests is established by the relevant engineering standards and regulatory requirements.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple experts assess the same data to establish a consensus ground truth. Since the performance data presented are primarily from bench and laboratory tests rather than clinical performance evaluations involving human interpretation, an adjudication method is not applicable and therefore not mentioned in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on demonstrating substantial equivalence to a predicate device through technological comparison and various non-clinical performance tests, not on comparing reader performance with and without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-In-The-Loop)
A standalone (algorithm only) performance study was not conducted or reported. The device, an endoscope, is a physical instrument for real-time imaging and aspiration, designed to be used by a medical professional. There is no mention of an independent algorithm component for which "standalone performance" without human interaction would be relevant.
7. Type of Ground Truth Used
The "ground truth" for the various performance tests is based on established engineering standards, regulatory guidance criteria, and design specifications. For example:
- Ultrasound output: Conformance to IEC 60601-2-37 limits.
- Reprocessing: Meeting efficacy requirements as outlined in FDA reprocessing guidance.
- Biocompatibility: Absence of adverse biological reactions as per ISO 10993-1.
- Software: Verification against software requirements specifications and cybersecurity guidelines.
- Electrical Safety/EMC: Conformity to IEC standards.
- Bench Performance (Thermal/Mechanical): Meeting predefined design requirements and durability targets.
There is no mention of clinical ground truth types like expert consensus, pathology, or outcomes data, as this is a pre-market submission focused on fundamental device safety and performance rather than clinical effectiveness.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided. The BF-UC190F is an endoscopic device, not an AI/Machine Learning algorithm that requires a "training set" of data. The "training" for such a device occurs during its design and development through iterative engineering, testing, and validation against established standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of this device. The "ground truth" for the device's development and validation (not a training set) involved adherence to engineering principles, scientific validation methods, and regulatory requirements (as outlined in point 7), established through industry standards, guidance documents, and internal design specifications.
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